Impact of Mind-Body Interventions Post Organ Transplant

University Of Minnesota Twin Cities, Minneapolis MN

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Abstract

DESCRIPTION (provided by applicant): Solid organ transplant recipients require life-long immunosuppressive therapy that leads to side effects, complications and chronic symptoms, and reduces health-related quality of life. Pharmacologic options for managing symptoms increase the risks of side effects and drug interactions, and may reduce adherence by complicating an already challenging medication regimen. In contrast, mind-body based complementary therapies, such as mindfulness-based stress reduction (MBSR), may be ideal to treat distressing symptoms and negative emotions after transplantation. Our long-range objective is to develop evidence-based recommendations for non-pharmacologic strategies that provide symptom relief to transplant recipients, and are safe, practical and cost-effective. The specific aims are to: 1) Test the effectiveness of a MBSR program on symptom management (as measured by well-validated, self-report scales for symptoms of depression, anxiety and sleep disturbance), objective sleep changes, health-related quality of life and overall quality of life in transplant recipients at 6- and 12-mos follow-up; and 2) Evaluate the impact of this MBSR program on health care utilization and costs at 6- and 12-mos follow-up. We will randomize patients (N=150) to: 1) a MBSR intervention arm (8 wks of group instruction in mindfulness meditation techniques followed by home practice combined with individualized telephone monitoring); or 2) a health education (HE) active control arm, delivered in a format to match MBSR for instructor attention and group support. The sample will consist of kidney, kidney/pancreas, pancreas, lung, liver, heart or heart-lung transplant recipients at least 6-mo after transplant surgery. A two-stage randomization scheme will form a temporary, Delayed-Intervention (DI) inactive control arm for internal validation. The DI group will be randomized to MBSR or HE after 26 weeks of observation. This is a low cost, low risk intervention that, if successful, could be replicated easily, and result in important reductions in health care costs while improving the well being of patients with organ transplants.